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Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay in Postmenopausal Women with Node-Positive, Estrogen- Receptor-Positive Breast Cancer on Chemotherapy: A Retrospective Analysis of a Randomised Trial. Albain KS et al. Lancet Oncol 2010;11(1):55-65. Albain KS et al.
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Prognostic and Predictive Valueof the 21-Gene Recurrence Score Assay in Postmenopausal Women with Node-Positive, Estrogen- Receptor-Positive Breast Canceron Chemotherapy: A Retrospective Analysis of a Randomised Trial Albain KS et al. Lancet Oncol 2010;11(1):55-65. Albain KS et al. San Antonio Breast Cancer Symposium 2009;Abstract 112.
Introduction • A low 21-gene recurrence score (RS) in postmenopausal patients with ER-positive, node-negative breast cancer predicts a lack of benefit from the addition of chemotherapy to tamoxifen (T) treatment (JCO 2006;24:3726). • The value of the 21-gene recurrence score assay in patients with ER-positive, node-positive breast cancer that are treated with T alone is unknown. • Current study objectives: • Assess prognostic value of the 21-gene recurrence score in patients with node-positive breast cancer treated only with T. • Assess whether 21-gene recurrence assay allows for the prediction of a node-positive subset of patients who do not benefit from anthracycline-based chemotherapy. Albain KS et al. Lancet Oncol 2010;11(1):55-65.
SWOG-8814: Parent Trial Schema Tamoxifen (T) Tamoxifen 20 mg PO QD x 5 yrs CAF-T CAF x 6 Cycles T x 20 mg PO QD x 5 yrs R CAFT* CAF x 6 Cycles Concurrent T 20 mg PO QD x 5 yrs CAF = Doxorubicin 30 mg/m2 day 1, day 8 Cyclophosphamide 100 mg/m2 PO days 1-14 5-FU 500 mg/m2 day 1, day 8; Cycle repeated q 28 days * Excluded from analysis due to inferior efficacy Albain KS et al. Lancet Oncol 2010;11(1):55-65.
SWOG-8814: Translational Study 1,477 patients randomly assigned to trial 664 tumor samples available from central banking 601 samples analyzed by RT PCR: 148 T alone; 219 CAF T; 234 CAFT 367 final samples for this analysis (Tamoxifen and CAF-T groups only;CAFT group excluded due to inferior efficacy) Primary analysis: Cox regression model using continuous RSSecondary analysis: RS categories, low (<18), intermediate (18-30) and high (≥31) Albain KS et al. Lancet Oncol 2010;11(1):55-65.
Ten-Year Disease-Free Survival(DFS) and Overall Survival (OS)in Tamoxifen Alone Group *Log-rank p-value stratified according to the number of positive nodes (1-3 vs ≥4 positive nodes). Albain KS et al. Lancet Oncol 2010;11(1):55-65.
Hazard Ratio: Ten-Year DFS,T versus CAF-T Groups *Log-rank p-value stratified according to the number of positive nodes (1-3 vs ≥4 positive nodes); HR = hazard ratio. Albain KS et al. Lancet Oncol 2010;11(1):55-65.
Conclusions • The RS is prognostic for patients with node-positive breast cancer treated with tamoxifen alone. • A high RS score predicts an improved DFS in patients with node-positive breast cancer treated with anthracyline-based chemotherapy followed by tamoxifen compared to tamoxifen alone. • A low RS score identifies women with node-positive breast cancer who may not benefit from the addition of anthracycline-based chemotherapy to tamoxifen treatment. Albain KS et al. Lancet Oncol 2010;11(1):55-65.
Conclusions (Continued) “Prospective studies with larger sample sizes are essential to establish who benefits most from modern endocrine therapy plus chemotherapy, and whetheruse of multigene assays affects survival.” - KS Albain Albain KS et al. Lancet Oncol 2010;11(1):55-65.
Fondazione Michelangelo Phase III Trial in HER2-Negative Conventionally High-Risk Patients (Node-Positive and/or T2-T3) Oncotype DX Recurrence Score Study OneHigher risk (RS > 18) Study TwoLower risk (RS ≤ 18) *Randomized by RS >11 vs ≤18 R R * Ixabepilone CMF FEC AT CMF AT CMF Endocrine therapy Endocrine therapy(if ER- and/or PR-positive) Gianni L. Personal Communication. December 2009; Gianni L. Presentation. Research To Practice Satellite Symposium, San Antonio Breast Cancer Symposium 2009; www.fondazionemichelangelo.org.
